Quality Systems Specialist Ii - Foster City, United States - Gilead Sciences

Gilead Sciences

Verified Company

Foster City, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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At Gilead, we're creating a healthier world for all people.

For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

Join Gilead and help create possible, together.

Job Description:

Job Description:

Reporting to the Global Quality Systems and Compliance organization, the Quality Systems Specialist II -Learning Management Systems will be responsible for partnering with Business Leaders to drive user-focused strategies to ensure effective and compliant training is delivered to the Pharmaceutical Development and Manufacturing organization of Gilead.

This role is for a thought leader who is ready to evolve and modernize the training experience by implementing user focused learning strategies and tools into the organization.

Quality Systems Specialist II

Responsibilities:

Lead and enhance the PDM Training Program to ensure compliance with current Good Manufacturing Practices (cGMPs) and to support operational excellence initiatives.
Evaluate LMS system releases and participate in testing as necessary.
Collaborate with managers to establish curriculum requirements for new and existing employees and to identify future training opportunities.
Collaborate crossfunctionally to ensure accurate implementation and revision of curricula and to ensure training records are processed appropriately and timely.
Participate in writing or suggesting changes to controlled documents (e.g., SOPs, Work Instructions, Business Enabling Documents).
Provide direction, guidance, and technical knowledge to more junior staff.
Develop, enhance, and deliver training administration content to new staff.
Track, measure, and distribute actionable metrics and KPIs to assess and improve training administration effectiveness.
Identify and escalate compliance gaps across quality systems.
Develop solutions to moderately complex problems and evaluate impact as necessary.
May assist with compliance audits as required.
Provide excellent customer service.
Lead by example to foster a commitment to quality in personnel and a culture of quality within the organization.
Normally receives mínimal instruction on routine work and general instructions on new assignments.

Basic Qualifications:

4+ years of relevant experience and a BS or BA degree. OR 2+ years of relevant experience and a MS degree.

Preferred Qualifications

Proven analytical and conceptual skills.
Excellent verbal communication, technical writing, and interpersonal skills.
Demonstrates strong understanding of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).
Demonstrates proficient understanding of roles and functions within the Pharmaceutical Development and Manufacturing organization.
Demonstrates functional and process knowledge to support the integrated design and development of training programs.
Demonstrates ability to effectively work with crossfunctional project teams and manage multiple projects/priorities.
Demonstrates excellent verbal, technical writing, and interpersonal communication skills.
Proven organizational skills, analytical and conceptual skills, and ability to work effectively within teams.
Demonstrates intellectual curiosity, desire to learn, and ability to problemsolve.
Ability to affect decisions, guide and communicate effectively with stakeholders, build collaborative relationships, and understand functional processes and goals.
Ability to effectively manage multiple projects/priorities.
Ability to quickly adapt to changing circumstances; recognizes risks, escalates, and reprioritizes accordingly.
Prior experience with a Learning Management System (LMS).
Prior experience in pharmaceutical industry is strongly preferred.

The salary range for this position is: $99, $129, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geog